VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, presents the data summary below in conjunction with our Late-Breaking Clinical Trials Livestream on June 25, 2020.
Presenter: A/Prof Tjun Tang, MD, on behalf of the MERLION Investigators
Singapore General Hospital, Singapore
The MERLION Trial is a prospective, non-randomized, single arm, observational, multicenter clinical study evaluating the safety and efficacy of the iVascular Luminor™ drug-coated balloon (DCB) and Angiolite™ drug-eluting stent (DES) for treatment of TASC C and D tibial occlusive lesions in Asian patients presenting with chronic limb threatening ischemia (CLTI) from Singapore.
The clinical primary endpoints were freedom from major adverse events, which was a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target lower extremity amputation (LEA) and clinically driven target lesion revascularization (TLR), defined as any re-intervention performed for ≥50% diameter restenosis of the target lesion after documentation of recurrent clinical symptoms.
50 patients (66 atherosclerotic lesions) were treated with 77 Luminor™ DCB and 4 Angiolite™ DES. 94% had diabetes mellitus (DM), 50.0% end stage renal failure (ESRF) and 80% were non-smokers. 88% patients presented with Rutherford Score 5 and 6 wounds. 71.2% lesions treated were de novo in nature, 60.6% were TASC C lesions and the mean lesion length treated was 13.7 ± 9.5cm. 51.5% lesions were moderately to severely calcified in nature.
There was 100% technical success. 3/66 (4.5%) lesions required bailout stenting for severe flow limiting dissections, using the Angiolite™ DES. There were no deaths within 30 days of intervention. Six-month amputation free survival (AFS) was 86.0% (3 deaths and 4 major LEA). Target lesion primary patency at 6 months was 78.9% (52/57 lesions), freedom from TLR was 91.2% (45/57 lesions) and 68.3% had ≥1 category improvement in Rutherford Score.
The iVascular Luminor™ DCB is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of DM and ESRF. It is associated with a high technical success rate, 6-month target lesion patency and AFS.
About VIVA Physicians
VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by VIVA Physicians have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about VIVA Physicians, visit www.vivaphysicians.org.
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